MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_ACCOLADE STEM SIZE 3.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number UNK_SHC

Device Problems Degraded (1153); Material Erosion (1214)

Patient Problems Foreign Body Reaction (1868); Unequal Limb Length (4534)

Event Date 02/16/2021

Event Type  Injury  

Manufacturer Narrative

Reported event: an event regarding alleged altr , fretting and limb length discrepancy involving an unknown implant accolade stem was reported.The event was not confirmed.Method & results: product evaluation and results: not performed as no items were returned.Clinician review: no medical records were received for review with a clinical consultant.Product history review: not performed as device is not identified properly.Complaint history review: not performed as device is not identified properly.Conclusions: it was reported that patient was revised due to altr , fretting and limb length discrepancy involving an unknown implant accolade stem.The exact cause of the event could not be determined because product is not properly identified and no further investigation for this event is possible at this time as no devices was received by stryker orthopedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

It was reported that the patient presented with a pseudotumor in the right hip which required a revision.During the revision it was discovered that the patient also appeared to have severe trunnionosis.Update 18/february/2021 wg: also noted in 'patient details' image: "right leg 0.5cm shorter.".

Event Description

It was reported that the patient presented with a pseudotumor in the right hip which required a revision.During the revision it was discovered that the patient also appeared to have severe trunnionosis.Update 18/february/2021 wg: also noted in 'patient details' image: "right leg 0.5cm shorter.".

Manufacturer Narrative

Reported event: an event regarding altr, fretting and limb length discrepancy involving an unknown accolade stem was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remained implanted.Clinician review: a review of the provided medical information by a clinical consultant indicated: "2 ap right hip demonstrating uncemented tha, reduced, nominal position, no gross pathology noted.Undated, unlabeled mri cut right hip consistent with tha in situ with soft tissue and/or fluid around proximal femur.No clinical or pmh, no patient demographics, no operative reports, no surgical pathology reports, no examination of explanted components, no dated serial x-rays or complete imaging studies, no baseline values of cobalt or chrome studies.Based upon the information available for review, neither confirmation of the event description nor preparation of a medical report is possible for this case." product history review: could not be performed as the device lot details were not provided.Complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient's right hip was revised due to pseudotumor, severe trunnionosis and limb length discrepancy (i.E.0.5cm shorter).The exact cause of the event could not be determined because insufficient information was provided.Further information such as clinical or patient medical history (pmh), patient demographics, operative reports, surgical pathology reports, examination of explanted components, dated serial x-rays or complete imaging studies, and baseline values of cobalt or chrome studies are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: UNKNOWN_ACCOLADE STEM SIZE 3.5
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 11495612
• MDR Text Key: 240319343
• Report Number: 0002249697-2021-00470
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/17/2021
• Initial Date FDA Received: 03/16/2021
• Supplement Dates Manufacturer Received: 04/09/2021
• Supplement Dates FDA Received: 04/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 83 YR